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June 22, 2007

Johnson & Johnson Press Release regarding Risperdal for Children and Adolescents with Bipolar Disorder and Schizophrenia

Though Psychiatrists have been prescribing Risperdal to children and adolescents for a variety of symptoms and disorders, the FDA has not yet approved of its use with these age groups for treatment of Bipolar Disorder and Schizophrenia. Recently Johnsons & Johnson released information that FDA approval is the process, and will soon be finalized.

"Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced it has received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding two supplemental New Drug Applications (sNDA) for RISPERDAL (risperidone), filed on Dec. 21, 2006. The sNDAs are for the treatment of schizophrenia in adolescents ages 13-17 years and for the short-term treatment of bipolar mania associated with bipolar I disorder in children and adolescents ages 10-17 years, respectively. The FDA has not asked for any additional studies. J&JPRD is currently reviewing the approvable letter and looks forward to finalizing the label with the agency."

Read Full Press Release:

FDA Issues Approvable Letter for RISPERDAL to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania


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